JP2003525092A - Balloon structure with PTFE parts - Google Patents
Balloon structure with PTFE partsInfo
- Publication number
- JP2003525092A JP2003525092A JP2001563173A JP2001563173A JP2003525092A JP 2003525092 A JP2003525092 A JP 2003525092A JP 2001563173 A JP2001563173 A JP 2001563173A JP 2001563173 A JP2001563173 A JP 2001563173A JP 2003525092 A JP2003525092 A JP 2003525092A
- Authority
- JP
- Japan
- Prior art keywords
- tube
- balloon
- layer
- intermediate layer
- medical balloon
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
- Y10T428/1393—Multilayer [continuous layer]
Abstract
Description
【0001】
(本発明の技術分野)
本発明は、少なくとも部分的にポリテトラフルオロエチレンから形成された医
療用バルーン一般に関する。TECHNICAL FIELD OF THE INVENTION This invention relates generally to medical balloons formed at least in part from polytetrafluoroethylene.
【0002】
(本発明の背景技術)
ステントなど医療用具の拡張及び配置のためのみならず、身体血管の拡張のた
めに医療用バルーンを使用することが公知である。医療用バルーンは、単一の材
料層、或いは多数の材料層から形成され得る。多層のバルーンの場合には、多数
の層が同一又は異なる材料であってもよい。BACKGROUND OF THE INVENTION It is known to use medical balloons not only for the expansion and placement of medical devices such as stents, but also for the expansion of body vessels. The medical balloon can be formed from a single material layer or multiple material layers. In the case of a multilayer balloon, multiple layers may be the same or different materials.
【0003】
医療用バルーンを形成するために様々な材料が使用されている。これら材料に
は、熱可塑性ポリウレタン(TPU)、ポリエチレン、ノンコンプライアント(
non−compliant)PETを含むポリエチレンテレフタレート(PE
T)などのポリエステル、アーニテル樹脂、ハイトレル、ポリエーテルエーテル
ケトン(PEEK)、ポリエーテルポリマーとエルムアトケムノースアメリカか
ら入手可能なペバックス(登録商標)(あらゆるグレード)などのポリアミドと
のブロックコポリマー、ポリエーテルと米国デラウェア州ウィルミントンのイー
アイ デュポン ドヌムール アンド カンパニーから入手可能なハイトレル
(登録商標)などのポリエステルポリマーとのブロックコポリマー、テフロン(
登録商標)、ナイロン−11及びナイロン−12などのポリアミド、ブロックポ
リイミド、ポリテトラフルオロエチレン(PTFE)、ポリエチレン(PE)及
びポリプロピレン(PP)などのポリオレフィン、SBR及びEPDMを含む合
成ゴム、及び他のポリオレフィン及びシリコーンエラストマーが含まれる。冠状
動脈の血管形成の中で使用されるカテーテルバルーンについては、好適なポリマ
ー製基材はPET、ナイロン及びPBである。材料の特定の選択は、バルーンに
所望の特性に依存する。Various materials have been used to form medical balloons. These materials include thermoplastic polyurethane (TPU), polyethylene, non-compliant (
Polyethylene terephthalate (PE) containing non-compliant PET
T) such as polyesters, Arnitel resins, Hytrel, polyetheretherketones (PEEK), block copolymers of polyether polymers with polyamides such as Pebax® (all grades) available from Elmuato Chem North America, poly Teflon, a block copolymer of ether and a polyester polymer such as Hytrel® available from EI Dupont Donumur & Co., Wilmington, Del.
(Registered trademark), polyamides such as nylon-11 and nylon-12, block polyimides, polyolefins such as polytetrafluoroethylene (PTFE), polyethylene (PE) and polypropylene (PP), synthetic rubbers including SBR and EPDM, and others. Included are polyolefins and silicone elastomers. For catheter balloons used in coronary angioplasty, suitable polymeric substrates are PET, nylon and PB. The particular choice of material depends on the desired properties of the balloon.
【0004】
これら材料のうち、PTFEは、その低い摩擦係数、耐薬品性、可撓性及び強
度のために医療用バルーンに関心が寄せられている。しかしながらPTFEの物
理的性質のために、この材料は、従来の熱可塑性エラストマーの加工と同一の方
法で加工できない。Of these materials, PTFE is of interest for medical balloons because of its low coefficient of friction, chemical resistance, flexibility and strength. However, due to the physical properties of PTFE, this material cannot be processed in the same way as the processing of conventional thermoplastic elastomers.
【0005】
バルーンなどの埋込可能な医療用器具におけるポリテトラフルオロエチレン(
PTFE)及び拡張PTFE(EPTFE)の使用は、米国特許第575293
4号及び米国特許5868704号に開示されている。これらは両方とも、多孔
性のEPTFE層と、可撓性又は非可撓性の層で構成されたバルーンを開示して
いる。EPTFE膜は、バルーン用のコート、又は外部層の形態をなすバルーン
に一体化された部品としての役割を果たし得る。その文献に示されたバルーンは
、らせん状に巻回された多孔性EPTFEから形成される。一例において、バル
ーンのEPTFE部分を形成するために20層のEPTFE膜が使用される。そ
の結果、これらのバルーンは、大型の外形を有する傾向がある。Polytetrafluoroethylene in implantable medical devices such as balloons (
The use of PTFE) and expanded PTFE (EPTFE) is described in US Pat. No. 575293.
No. 4 and US Pat. No. 5,868,704. Both of these disclose balloons composed of a porous EPTFE layer and a flexible or inflexible layer. The EPTFE membrane may serve as a coat for the balloon or as an integral part of the balloon in the form of an outer layer. The balloon shown in that document is formed from spirally wound porous EPTFE. In one example, 20 layers of EPTFE membrane are used to form the EPTFE portion of the balloon. As a result, these balloons tend to have a large profile.
【0006】
PTFEバルーンの特性のうちのいくつかを有する一方で、小型の外形を有し
た医療用バルーンを製造することが望ましい。より詳細には、高い耐破裂強度及
び、繰り返された拡張/収縮サイクルの後にその拡張前の直径に戻る能力を有し
たノンコンプライアントEPTFEバルーンを提供することが本発明の目的であ
る。その目的のために、本発明は、内部のバルーン材料と外部のバルーン材料の
間に1つ以上のEPTFE層を有した医療用バルーンを提供する。It is desirable to manufacture medical balloons that have some of the properties of PTFE balloons, while having a small profile. More specifically, it is an object of the present invention to provide a non-compliant EPTFE balloon with high burst strength and the ability to return to its pre-expanded diameter after repeated expansion / contraction cycles. To that end, the invention provides a medical balloon having one or more EPTFE layers between an inner balloon material and an outer balloon material.
【0007】
本出願のあらゆる箇所にて言及された米国特許及び他のすべての出版された文
献は全て、それらの全体が参照によって本明細書に組み入れられる。
(発明の簡潔な要約)
本発明はEPTFE及び同様の材料をからなる医療用バルーン、並びにそのよ
うなバルーンが取り付けられたカテーテルに関する。本明細書に開示された医療
用バルーンは、少なくともその一部に内部層、中間層及び外部層を有する。内部
層と外部層との間に設けられた中間層は、EPTFEから形成される。内部及び
外部層には、熱可塑性材料、可撓性材料及び熱可塑性エラストマー材料を含む、
多様な材料が使用され得る。All US patents and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. BRIEF SUMMARY OF THE INVENTION The present invention relates to medical balloons made of EPTFE and similar materials, and catheters fitted with such balloons. The medical balloon disclosed in this specification has an inner layer, an intermediate layer, and an outer layer in at least a part thereof. The intermediate layer provided between the inner layer and the outer layer is made of EPTFE. The inner and outer layers include a thermoplastic material, a flexible material and a thermoplastic elastomer material,
A wide variety of materials can be used.
【0008】
中間の拡張PTFE層は、バルーンの全長に亙り延伸してもよく、或いはバル
ーンの一部分のみに延伸してもよい。
本発明は、破壊試験圧力に対してほぼ線形のコンプライアンス曲線を有した第
1部分、及び段階的なコンプライアンス曲線を有した第2部分を有したバルーン
に関する。The intermediate expanded PTFE layer may extend the entire length of the balloon, or may extend only a portion of the balloon. The present invention relates to a balloon having a first portion having a substantially linear compliance curve with respect to destructive test pressure and a second portion having a stepwise compliance curve.
【0009】
本発明のバルーンは、EPTFEチューブの内部及び外部に第1と第2材料を
コーティングすること、及び適切な温度において1つ以上のEPTFE層に対し
て内部及び外部材料層を積層することを含めて、様々な方法で形成され得る。代
替手段においてバルーンは、PTFE又はEPTFEチューブを他の材料の内部
及びチューブの間に挿入し、このチューブを張力、及び/又はブローイングなど
径方向に外側への圧力の使用によって好適な温度で適切に成形することにより形
成され得る。PTFEチューブが使用される場合、PTFEは、EPTFEチュ
ーブを形成すべく径方向にチューブを拡張する工程の間に拡張されてもよい。E
PTFEチューブは、押出成形されたPTFEのチューブを径方向の拡張とは別
に拡張することにより形成されてもよく、或いはチューブ形状に設けられたシー
ト状のEPTFEから形成されてもよい。The balloons of the present invention coat the inner and outer materials of the EPTFE tube with the first and second materials and laminate the inner and outer material layers to one or more EPTFE layers at a suitable temperature. Can be formed in various ways, including. In an alternative, the balloon is suitably inserted at a suitable temperature by inserting a PTFE or EPTFE tube inside and between the other materials and tensioning and / or using radially outward pressure such as blowing. It can be formed by molding. If a PTFE tube is used, the PTFE may be expanded during the step of radially expanding the tube to form an EPTFE tube. E
The PTFE tube may be formed by expanding the extruded PTFE tube separately from the radial expansion, or may be formed from a sheet-shaped EPTFE provided in a tube shape.
【0010】
本発明も本発明のバルーンを形成する方法にも関する。そのような方法の1つ
は内側及び外側にPTFE或いはEPTFEのチューブをコーティングする工程
を有する。別の方法は内部、外部及び中間のチューブを同心的に配置し、積層、
加熱、或いは他の適切な方式でチューブを一体に結合させる工程を伴う。さらな
る別の方法はバルーン材料の3つ以上の層を共に押し出す工程を伴う。The present invention also relates to methods of forming the balloons of the present invention. One such method involves coating PTFE or EPTFE tubing inside and outside. Another method is to arrange the inner, outer and middle tubes concentrically and stack,
This involves heating or otherwise joining the tubes together in any suitable manner. Yet another method involves co-extruding three or more layers of balloon material.
【0011】
本発明のカテーテルは、本明細書に開示された医療用バルーンをチューブの周
囲に配置し、同バルーンとの液体連通している拡張ルーメンを有する。本発明の
カテーテルは、拡張カテーテル、医療器具送達カテーテル、或いは医療用バルー
ンを運搬する他のカテーテルであってもよい。[0011] The catheter of the present invention has a medical balloon disclosed herein disposed about a tube and having an expansion lumen in fluid communication with the balloon. The catheter of the present invention may be a dilatation catheter, a medical device delivery catheter, or other catheter carrying a medical balloon.
【0012】
(発明の詳細な説明)
本発明は様々な形式で実施され得るが、本発明の特定の好適な実施形態がここ
に詳細に記載される。この記載は発明の原理の例示であり、本発明を例示された
特定の実施形態に制限するものではない。DETAILED DESCRIPTION OF THE INVENTION While the present invention may be embodied in various forms, certain preferred embodiments of the invention are described in detail herein. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
【0013】
本発明の医療用バルーンは、血管形成及び塞栓摘出術、並びに、ステント、グ
ラフト、ステントグラフト、及び大静脈フィルタなどの医療用具の拡張を含む、
様々な目的のために使用され得る。The medical balloon of the present invention includes angioplasty and embolectomy and expansion of medical devices such as stents, grafts, stent grafts, and vena cava filters.
It can be used for various purposes.
【0014】
本発明の医療用バルーンは、PTFE、EPTFE、或いは線状高密度ポリエ
チレンなどのフッ化されたポリマー材料の少なくとも1つの中間層が存在するこ
と一般を特徴とする。中間層は、中間層の材料と異なる第1のバルーン材料の内
部層と、中間層の材料と異なる第2のバルーン材料の外部層の間に配置される。
第1及び第2バルーン材料は同一、又は互いに異なり得る。The medical balloons of the present invention are generally characterized by the presence of at least one intermediate layer of fluorinated polymeric material such as PTFE, EPTFE, or linear high density polyethylene. The intermediate layer is disposed between an inner layer of a first balloon material different from the material of the intermediate layer and an outer layer of a second balloon material different from the material of the intermediate layer.
The first and second balloon materials can be the same or different from each other.
【0015】
PTFEの適切な形状は米国特許第5480711号に従って形成され得る。
PTFE材料の一例は、米国デラウェア州ウィルミントンのデュポン ドヌムー
ル アンド カンパニーによって、テフロン(登録商標)の商品名で製造されて
いる。適切なEPTFE膜は、米国特許第3953566号及び第418739
0号に従って形成され得る。図1Aに示されるEPTFEの形態では、小繊維が
すべて拡張の方向とほぼ平行な小繊維104によって相互に連結された結節点1
02から成る微細構造を有する。より好適には、ここに示された本発明のバルー
ンにて使用されるEPTFEは図1Bに示されるような、曲折した又は波状の小
繊維104によって相互に結合された結節点102から成る微構造を有する。米
国特許第5752934号に示されたこの後者のEPTFEの形態は、米国特許
第3953566号或いは米国特許第4187390号のいずれかに示されたE
PTFEより弾性を有し、5.5%以上の迅速な回復を特徴とする。参照した特
許はすべて、それらの全体が本明細書に組み入れられる。A suitable shape of PTFE may be formed according to US Pat. No. 5,480,711.
One example of PTFE material is manufactured by DuPont Donumur & Co., Wilmington, Del., Under the Teflon (R) trade name. Suitable EPTFE membranes are described in US Pat. Nos. 3,953,566 and 418,739.
No. 0 may be formed. In the form of EPTFE shown in FIG. 1A, a knot point 1 where the fibrils are all interconnected by fibrils 104 that are generally parallel to the direction of expansion.
Has a microstructure of 02. More preferably, the EPTFE used in the balloons of the present invention shown herein is a microstructure consisting of knots 102 interconnected by bent or wavy fibrils 104, as shown in FIG. 1B. Have. This latter form of EPTFE, shown in US Pat. No. 5,752,934, is shown in either US Pat. No. 3,953,566 or US Pat. No. 4,187,390.
It is more elastic than PTFE and is characterized by a quick recovery of 5.5% or more. All referenced patents are incorporated herein in their entirety.
【0016】
1つの実施形態の中で、図2に示されたように、本発明のバルーン112は、
内部層118、拡張PTFEから形成された中間層122、及び外部層126を
含む3つの層から形成される。図1に示される実施形態では、中間層122はバ
ルーン110の本体部130に亙り延伸する。In one embodiment, the balloon 112 of the present invention, as shown in FIG.
It is formed from three layers including an inner layer 118, an intermediate layer 122 formed from expanded PTFE, and an outer layer 126. In the embodiment shown in FIG. 1, the intermediate layer 122 extends across the body 130 of the balloon 110.
【0017】
図3に示される別の実施形態では、中間層122は、本体部分を越えて、基端
側及び末端側の錐体134部の少なくとも一部まで延伸する。
図4に示される別の実施形態では、中間層122は、基端側及び末端側胴部1
38の少なくとも一部に亙り拡張する。In another embodiment, shown in FIG. 3, the intermediate layer 122 extends beyond the body portion to at least a portion of the proximal and distal cones 134 portions. In another embodiment shown in FIG. 4, the intermediate layer 122 includes the proximal and distal barrels 1.
Extends over at least a portion of 38.
【0018】
図5に示される別の実施形態では、中間層122は、バルーン110の全長に
亙り内部層118及び外部層126と同一ともに延伸している。
本発明は、図6において112で示される箇所に内部層118、外部層126
及び中間層122を少なくとも有した医療用バルーンに関する。中間層122は
、内部層118及び外部層126によって包囲され、或いは被殻される。内部層
118及び外部層126は中間層122を包囲すべくともに結合される。図6に
示されるように、内部層118及び外部層126は基端側と末端側の胴部138
で結合される。それらは錐体部分134において結合されてもよい。In another embodiment, shown in FIG. 5, the intermediate layer 122 extends co-extensive with the inner layer 118 and outer layer 126 throughout the length of the balloon 110. According to the present invention, the inner layer 118 and the outer layer 126 are provided at the portions indicated by 112 in FIG.
And a medical balloon having at least the intermediate layer 122. The middle layer 122 is surrounded or shelled by the inner layer 118 and the outer layer 126. Inner layer 118 and outer layer 126 are bonded together to surround middle layer 122. As shown in FIG. 6, the inner layer 118 and the outer layer 126 have proximal and distal body portions 138.
Are joined by. They may be joined at the cone portion 134.
【0019】
さらに別の実施形態において、本発明は上記したように最内部層、同最内部層
より外側に設けられた最外部層、及び、最内部層と最外部層との間に設けられた
中間層を有した医療用バルーンに関する。中間層は、多数の繊維によって結節点
構造を結合している材料から形成される。そのような構造を有した適切な材料に
は、拡張PTFE及び高密度ポリエチレンが含まれる。好適には、繊維は曲折さ
れ、或いは波状である。In still another embodiment, the present invention is provided as described above, the innermost layer, the outermost layer provided outside the innermost layer, and between the innermost layer and the outermost layer. And a medical balloon having an intermediate layer. The intermediate layer is formed of a material that joins the knot structure with a number of fibers. Suitable materials having such a structure include expanded PTFE and high density polyethylene. Preferably the fibers are bent or wavy.
【0020】
さらに別の実施形態において、本発明は上記したように最内部層、同最内部層
より外側に設けられた最外部層、及び、最内部層と最外部層との間に設けられた
中間層を有した医療用バルーンに関する。中間層は、拡張されたときには多数の
繊維によって結節点構造を結合している材料から形成される。In yet another embodiment, the present invention is provided as described above, the innermost layer, the outermost layer provided outside the innermost layer, and between the innermost layer and the outermost layer. And a medical balloon having an intermediate layer. The intermediate layer is formed of a material that, when expanded, bonds the knot structure with multiple fibers.
【0021】
上記された本発明のバルーンは、低い拡張圧において正常な拡張、及び高圧に
てより小さな拡張を示すべく、内部の材料及び外部の材料の適切な選択によって
作製され得る。The balloons of the present invention described above can be made by appropriate selection of inner and outer materials to exhibit normal expansion at low expansion pressures and less expansion at high pressures.
【0022】
別の実施形態では、本発明は図7Aに112で示され、それぞれ130a及び
130bと表記された第1及び第2の隣接した本体長手方向部分を有したバルー
ンに関する。第1の本体部分130aは破壊圧力に対してほぼ直線形コンプライ
アンス曲線を有する。第2の本体部分130bは段階的なコンプライアンス曲線
を有する。同曲線は、第1本体部分の対応する区間と同様な線形の低圧区間と、
バルーンが第1本体部分に相対して急速に拡大する遷移区間と、第2部分のコン
プライアンス曲線が遷移領域に比べて緩慢に拡大する高圧区間とを特徴とする。
バルーン112は図7Bにおいて、第1及び第2本体部分のコンプライアンス曲
線がほぼ同一に線形となる圧力で、部分的に拡張した状態で示される。バルーン
112の断面図は図7Cに示される。内部層118及び外部層126はバルーン
の全長に亙り伸びている。中間層122は、バルーン両側の本体部分130aの
全長に亙り伸び、第2本体部分130bの領域では不連続である。不連続箇所は
132で示される。In another embodiment, the invention relates to a balloon, shown at 112 in FIG. 7A, having first and second adjacent body longitudinal portions labeled 130a and 130b, respectively. The first body portion 130a has a substantially linear compliance curve against burst pressure. The second body portion 130b has a graded compliance curve. The curve is a linear low pressure section similar to the corresponding section of the first body part,
It is characterized by a transition zone in which the balloon expands rapidly relative to the first body portion and a high pressure zone in which the compliance curve of the second portion expands slowly compared to the transition region.
Balloon 112 is shown in FIG. 7B in a partially expanded state at pressures at which the compliance curves of the first and second body portions are approximately the same linear. A cross-sectional view of balloon 112 is shown in Figure 7C. Inner layer 118 and outer layer 126 extend the entire length of the balloon. The intermediate layer 122 extends over the entire length of the body portions 130a on both sides of the balloon and is discontinuous in the region of the second body portion 130b. The discontinuity is shown at 132.
【0023】
図7A〜7Cの実施形態では、中間層がバルーンの第1部分に類似したコンプ
ライアンス曲線を特徴とする一方、内部材料及び外部材料は、バルーンの第2部
分に類似したコンプライアンス曲線を特徴とする。7A-7C, the intermediate layer features a compliance curve similar to the first portion of the balloon, while the inner and outer materials feature a compliance curve similar to the second portion of the balloon. And
【0024】
中間層は好適には、PTFE又は上記された拡張PTFEなどのフッ化された
コポリマー、或いは高密度ポリエチレンから形成される。
異なるコンプライアンス曲線を有した区間を特徴とするバルーンは、米国特許
第574985号、米国特許第5447497号及び米国特許第5358487
号により一般的に記載されている。これらは、参照によってそれらの全体におい
て本明細書に組み入れられる。The intermediate layer is preferably formed from fluorinated copolymers such as PTFE or expanded PTFE described above, or high density polyethylene. Balloons featuring sections with different compliance curves are described in US Pat. No. 574985, US Pat. No. 5,447,497 and US Pat. No. 5,358,487.
Are generally described by the issue. These are hereby incorporated by reference in their entirety.
【0025】
本発明は、バルーンと同様に本発明のバルーン予備的形成品も形成する方法に
も関する。そのような方法の1つでは、EPTFEで作られていたチューブが提
供される。EPTFEチューブは、押出成形されたPTFEチューブから形成さ
れ得る。そのチューブは適切な条件下で伸縮されたか、又は適切な条件下で伸縮
及び圧縮されている。適切な押出成形されたEPTFEチューブは、参照によっ
てその全体が本明細書に組み入れられた米国特許第5505887号に従って形
成され得る。EPTFEチューブは、1枚のEPTFE(好適にはほぼ平行又は
曲折された小繊維を備えたもの)をチューブ状に配置し、適温でチューブを加熱
することにより2つの隣接した縁部を密閉することによっても形成され得る。こ
のシートは、1層のEPTFE、或いは2層以上を含むEPTFEの多層から形
成され得る。層は、これら層の間のシールを形成すべく加熱されてもよい。The present invention also relates to methods of forming the balloon preforms of the present invention as well as the balloons. In one such method, a tube made of EPTFE is provided. EPTFE tubing may be formed from extruded PTFE tubing. The tube has been stretched under the proper conditions, or stretched and compressed under the proper conditions. A suitable extruded EPTFE tube can be formed according to US Pat. No. 5,505,887, which is incorporated herein by reference in its entirety. EPTFE tubing consists of a single EPTFE (preferably with approximately parallel or bent fibrils) arranged in a tube and sealing the two adjacent edges by heating the tubing at a suitable temperature. Can also be formed by. The sheet may be formed of one layer of EPTFE or multiple layers of EPTFE including two or more layers. The layers may be heated to form a seal between the layers.
【0026】
チューブの内部は第1の材料でコーティングされ、チューブの外側は第2の材
料でコーティングされる。チューブの内部及び外部に同じ材料が使用される場合
、コーティングは、コーティング材料のバスにチューブを浸すことにより、或い
は他の適切なコーティング技術によって遂行され得る。これには、コーティング
の噴霧、チューブに対するコーティングの塗布、チューブの内部及び外部に材料
を押出成形することが含まれる。チューブの内部及び外部に異なる材料が使用さ
れる場合、コーティングは、コーティングの噴霧、チューブに対するコーティン
グの塗布、材料の押出成形、或いは他の適切な塗布工程により塗布され得る。コ
ーティングされない部分が適切に被覆される場合、浸す方法が使用され得る。The inside of the tube is coated with a first material and the outside of the tube is coated with a second material. If the same material is used inside and outside the tube, coating can be accomplished by dipping the tube in a bath of coating material, or by any other suitable coating technique. This includes spraying the coating, applying the coating to the tube, and extruding material inside and outside the tube. If different materials are used inside and outside the tube, the coating may be applied by spraying the coating, applying the coating to the tube, extruding the material, or other suitable application process. A dipping method may be used if the uncoated part is properly covered.
【0027】
形成されたチューブは、直接バルーンとして、或いはより好適にはバルーンを
そこから形成すべく追加の加工を行うためのバルーン予備的形成品のいずれかと
して使用され得る。後者の場合では、当該技術分野において公知であるように、
予備的形成品は適切なバルーン成形技術によって予め設定された温度で成形され
うる。成形工程には、伸縮すべくバルーンへ張力を与えること、及び/又は予備
的形成品をブローイングすることにより一定の径方向に外部への力を与えること
が含まれ得る。The formed tube can be used either as a direct balloon or, more preferably, as a balloon preform for additional processing to form the balloon therefrom. In the latter case, as is known in the art,
The preform may be molded at a preset temperature by any suitable balloon molding technique. The molding process may include tensioning the balloon to stretch and / or applying a constant radial force by blowing the preform.
【0028】
好適には予備的形成品は、約700〜約1000℃の範囲の温度、及び、約2
0g〜200gの張力が与えられ、その後約1380kPa〜約4146kPa
(約200psi〜約600psi)の圧力でブローイングされる。言うまでも
なく、他の適切な操作上のパラメータも使用され得る。予備的形成品からのバル
ーンの形成は当技術において公知であり、例えば米国特許第4490421号、
米国特許第5807520号及び米国特許第5348538号に記載されている
。それらはすべて、参照によってそれらの全体が本明細書に組み入れられる。Preferably the preform is at a temperature in the range of about 700 to about 1000 ° C. and about 2
0 g to 200 g of tension is applied, and then about 1380 kPa to about 4146 kPa.
Blown at a pressure (about 200 psi to about 600 psi). Of course, other suitable operational parameters may also be used. The formation of balloons from preformed articles is known in the art, eg US Pat. No. 4,490,421,
It is described in US Pat. No. 5,807,520 and US Pat. No. 5,348,538. They are all incorporated herein by reference in their entirety.
【0029】
EPTFE層を備えたバルーンは、PTFE層を有したチューブ状予備的形成
品を径方向に拡張することによっても作製され得る。
その発明は、さらに本発明のバルーンを形成方法にも関する。この方法は、第
1、第2及び第3チューブを提供する工程と、第1チューブを第2チューブに挿
入する工程と、第3チューブに第2チューブを挿入する工程と、バルーン成形用
型に第1、第2及び第3チューブを挿入する工程と、バルーンを形成すべく第1
、第2及び第3チューブを好適な温度で拡張する工程とを有する。第2のチュー
ブはEPTFEから形成される。Balloons with an EPTFE layer can also be made by radially expanding a tubular preform with a PTFE layer. The invention further relates to a method of forming the balloon of the present invention. This method comprises the steps of providing first, second and third tubes, inserting the first tube into the second tube, inserting the second tube into the third tube, and forming a balloon mold. Inserting the first, second and third tubes and first to form a balloon
, And expanding the second and third tubes at a suitable temperature. The second tube is made of EPTFE.
【0030】
本発明のバルーンを形成する別の方法は、バルーン予備的形成品を形成すべく
第1、第2及び第3材料を共に押出成形する工程を有する。第2の材料はPTF
Eなどのフッ化されたコポリマー、或いは高密度ポリエチレンであり、第1及び
第2材料の間に配置される。EPTFEチューブが好適である場合、バルーン予
備的形成品は伸縮され、EPTFEを形成すべく処理され得る。形成されたバル
ーン予備的形成品はバルーンを形成すべく成形され得る。成形は所望の温度で実
行され得る。成形、予備的形成品を張力下に配置することによって、予備的形成
品をブローイングすることによって、バルーンを張力の下に配置しかつバルーン
をブローイングする組合せによって、或いは当技術にて公知の他の適切な技術に
よって実行され得る。Another method of forming the balloon of the present invention comprises co-extruding the first, second and third materials together to form a balloon preform. The second material is PTF
A fluorinated copolymer such as E, or high density polyethylene, disposed between the first and second materials. If EPTFE tubing is preferred, the balloon preform can be stretched and processed to form EPTFE. The formed balloon preform may be shaped to form a balloon. Molding can be performed at any desired temperature. Molding, by placing the preform under tension, by blowing the preform, by a combination of placing the balloon under tension and blowing the balloon, or other known in the art. It can be performed by any suitable technique.
【0031】
本発明のバルーンは、第1材料の第1チューブを提供し、シート状のPTFE
、EPTFE、高密度ポリエチレン又は本明細書に示される他の適切な材料を第
1のチューブの周囲に配置するによっても形成され得る。その後、第2材料が第
1チューブの周囲に配置されるか、或いは、第1のチューブがバルーンの外殻の
役割を果たす第2材料の第2チューブ内に配置され得る。その後、材料は、それ
らをともに積層し、或いは外部の第2材料へ第1チューブ材料を積層させるべく
加熱される。材料は当技術において公知の適切な接着剤を使用して、ともに接着
され得る。The balloon of the present invention provides a first tube of a first material, which is a sheet of PTFE.
, EPTFE, high density polyethylene, or other suitable material shown herein may also be formed by placing it around the first tube. The second material may then be placed around the first tube, or the first tube may be placed within a second tube of second material that acts as the outer shell of the balloon. The materials are then heated to either laminate them together or to laminate the first tube material to the outer second material. The materials can be glued together using any suitable adhesive known in the art.
【0032】
PTFEの中間層がバルーン予備的形成品に使用される場合には、予備的形成
品中のPTFE層が完成したバルーンではEPTFE層に変形されるべく、PT
FEは予備的形成品をブローイングすることによって拡張され得る点を注記する
。If an intermediate layer of PTFE is used in the balloon preform, the PTFE layer in the preform will be transformed into an EPTFE layer in the finished balloon so that the PT
Note that the FE can be expanded by blowing the preform.
【0033】
積層されたバルーン予備的形成品をブローイングすると直ちに、PTFE、E
PTFE、ポリエチレン等などの中間層が内部及び外部層から離層する場合があ
り、そのために中間層を包囲することがある点もさらに注記する。Immediately upon blowing the laminated balloon preform, PTFE, E
It is further noted that an intermediate layer such as PTFE, polyethylene, etc. may delaminate from the inner and outer layers, and thus may surround the intermediate layer.
【0034】
別の実施形態において本発明は、その上に医療用バルーンを配置するカテーテ
ルにも関する。図8は、カテーテルチューブ210の周囲に設けられたバルーン
212を示す。ガイドワイヤ213がカテーテルチューブ210を貫通している
。カテーテルチューブ210はバルーン212と液体連通にある。代替手段にお
いては、バルーンを拡張させるべく個別の拡張ルーメン(図示せず)が設けられ
得る。図8にさらに示されるように、カテーテル210は、内部に傷216を有
した血管214内にある。バルーン212は傷216内に配置され、血管の拡張
直前の部分的に拡張した状態が示される。In another embodiment, the invention also relates to a catheter on which a medical balloon is placed. FIG. 8 shows a balloon 212 provided around the catheter tube 210. A guide wire 213 penetrates the catheter tube 210. Catheter tube 210 is in fluid communication with balloon 212. In the alternative, a separate inflation lumen (not shown) may be provided to inflate the balloon. As further shown in FIG. 8, the catheter 210 is within a blood vessel 214 having a wound 216 therein. The balloon 212 is positioned within the wound 216 and is shown in a partially expanded state just prior to the expansion of the blood vessel.
【0035】
ここに示された本発明のバルーンは、3層のバルーンに限定されない。本発明
のバルーンはより一般に、フッ化されたコポリマー及び上記の高密度ポリエチレ
ンからなるグループから選択された材料の少なくとも1つの中間層を備えた3つ
以上の材料層から形成され得る。The inventive balloons shown here are not limited to three-layer balloons. The balloons of the present invention may more generally be formed of three or more material layers with at least one intermediate layer of a material selected from the group consisting of fluorinated copolymers and high density polyethylene as described above.
【0036】
本発明は、本発明のバルーンを使用可能な医療器具送達カテーテルを含む他の
種類のカテーテルにも関する。1つのそのような適切なステント送達カテーテル
はバーバ(Vrba)の米国特許第5772669号に開示される。本発明のカ
テーテルは、当技術にて公知のオーバーザワイヤのデザイン、固定ワイヤのデザ
イン、迅速交換のデザイン、或いは他の適切なデザインであってもよい。The present invention also relates to other types of catheters, including medical device delivery catheters that can use the balloons of the present invention. One such suitable stent delivery catheter is disclosed in US Pat. No. 5,772,669 to Vrba. The catheter of the present invention may have an over-the-wire design, a fixed wire design, a rapid exchange design, or any other suitable design known in the art.
【0037】
上記の開示は、本発明の例示であり排他的なものではない。この記載事項は、
当業者に多数の変形及び代替手段を示唆する。これらの代替手段及び変形は全て
付属のクレームの範囲に包含されるものである。当業者は、本明細書に記載した
特定の実施形態に対する等価物も認識し得るが、これら等価物も付属のクレーム
に包含されるものである。The above disclosure is illustrative of the present invention and not exclusive. This information is
Many variations and alternatives will suggest themselves to those skilled in the art. All such alternatives and modifications are within the scope of the appended claims. Those skilled in the art will recognize equivalents to the specific embodiments described herein, which equivalents are also encompassed by the appended claims.
【0038】
(実施例)
(実施例1)
構造バルーンの外部及び内部層が、アーニテル樹脂(登録商標)EM−740
から形成されたチューブ状予備的形成品から形成された。中間層はEPTFEか
ら形成された。2本のアーニテル樹脂(登録商標)EM−740チューブは、内
径、外径として内部チューブについてそれぞれ0.043cm(0.017イン
チ)及び0.079cm(0.03 1インチ)、外部チューブについてそれぞ
れ0.127cm(0.050インチ)及び0.152cm(0.060インチ
)を有していた。その後、チューブは同軸に組み立てられてサンドイッチ構造に
帰着した。また、アッセンブリはEPTFEチューブを伸長せずに、室温にて伸
縮された。Example 1 Example 1 The outer and inner layers of the structural balloon are Arnitel Resin® EM-740.
Formed from a tubular preform formed from The intermediate layer was made of EPTFE. The two Arnitel® EM-740 tubes have 0.043 cm (0.017 inch) and 0.079 cm (0.031 inch) inner and outer diameters respectively for the inner tube and 0 for the outer tube. It had 0.127 cm (0.050 inches) and 0.152 cm (0.060 inches). The tubes were then coaxially assembled resulting in a sandwich structure. Also, the assembly was expanded and contracted at room temperature without extending the EPTFE tube.
【0039】
その後サンドイッチ構造は型に挿入され、95℃で31気圧(450psi)
及び70グラムの張力のブローイング圧にて、3.0mmのバルーンが形成され
た。形成された3層バルーンは0.00643cm(0.00253インチ)の
壁厚、6〜12気圧において5.1%及び12〜18気圧において5.5%のコ
ンプライアンスを有していた。また、破壊圧力は24気圧(353psi)であ
った。The sandwich structure was then inserted into the mold and heated at 95 ° C. at 31 atmospheres (450 psi).
And a blowing pressure of 70 grams tension formed a 3.0 mm balloon. The three layer balloon formed had a wall thickness of 0.00643 cm (0.00253 inches), a compliance of 5.1% at 6-12 atmospheres and 5.5% at 12-18 atmospheres. The breaking pressure was 24 atm (353 psi).
【0040】
形成されたバルーンはアーニテル樹脂(登録商標)EM−740から同一壁厚
で形成された単層バルーンよりはるかに高い耐穿孔抵抗を有していた。
形成されたバルーンはサンドイッチ構造を有していた。The formed balloons had much higher resistance to puncture than single layer balloons made from Arnitel® EM-740 with the same wall thickness. The formed balloon had a sandwich structure.
【図1A】 ほぼ平行の小繊維を有したEPTFEの結節点及び小繊維の構
造を示す概念図。FIG. 1A is a conceptual diagram showing the structure of EPTFE nodes and fibrils having fibrils that are substantially parallel to each other.
【図1B】 小繊維が曲折しているEPTFEの結節点及び小繊維の構造を
示す概念図。FIG. 1B is a conceptual diagram showing the structure of EPTFE nodes and fibrils in which the fibrils are bent.
【図2】 バルーンの本体部のみに亙り延伸する中間層を備えた医療用バル
ーンを示す長手方向断面図。FIG. 2 is a longitudinal cross-sectional view showing a medical balloon having an intermediate layer extending only over the main body of the balloon.
【図3】 バルーンの錐体部分に亙り延伸する中間層を備えた医療用バルー
ンを示す長手方向断面図。FIG. 3 is a longitudinal cross-sectional view showing a medical balloon including an intermediate layer extending over a cone portion of the balloon.
【図4】 バルーンの胴部の一部に亙り延伸する中間層を備えた医療用バル
ーンを示す長手方向断面図。FIG. 4 is a longitudinal cross-sectional view showing a medical balloon including an intermediate layer extending over a part of the body of the balloon.
【図5】 バルーンの胴部に亙り延伸する中間層を備えた医療用バルーンを
示す長手方向断面図。FIG. 5 is a longitudinal cross-sectional view showing a medical balloon including an intermediate layer extending over the body of the balloon.
【図6】 包囲された中間層を備えた医療用バルーンを示す長手方向断面図
。FIG. 6 is a longitudinal cross-sectional view showing a medical balloon with an enclosed intermediate layer.
【図7A】 完全に拡張したバルーンを概略的に示す側面図。FIG. 7A is a side view schematically illustrating a fully inflated balloon.
【図7B】 部分的に拡張したバルーンを概略的に示す側面図。FIG. 7B is a side view schematically illustrating a partially expanded balloon.
【図7C】 図7Bの直線8−8におけるバルーンの長手方向断面図。7C is a longitudinal cross-sectional view of the balloon along line 8-8 of FIG. 7B.
【図8】 カテーテル上に取り付けられたバルーンを示す概念図。FIG. 8 is a conceptual diagram showing a balloon mounted on a catheter.
───────────────────────────────────────────────────── フロントページの続き (81)指定国 EP(AT,BE,CH,CY, DE,DK,ES,FI,FR,GB,GR,IE,I T,LU,MC,NL,PT,SE,TR),OA(BF ,BJ,CF,CG,CI,CM,GA,GN,GW, ML,MR,NE,SN,TD,TG),AP(GH,G M,KE,LS,MW,MZ,SD,SL,SZ,TZ ,UG,ZW),EA(AM,AZ,BY,KG,KZ, MD,RU,TJ,TM),AE,AG,AL,AM, AT,AU,AZ,BA,BB,BG,BR,BY,B Z,CA,CH,CN,CR,CU,CZ,DE,DK ,DM,DZ,EE,ES,FI,GB,GD,GE, GH,GM,HR,HU,ID,IL,IN,IS,J P,KE,KG,KP,KR,KZ,LC,LK,LR ,LS,LT,LU,LV,MA,MD,MG,MK, MN,MW,MX,MZ,NO,NZ,PL,PT,R O,RU,SD,SE,SG,SI,SK,SL,TJ ,TM,TR,TT,TZ,UA,UG,UZ,VN, YU,ZA,ZW Fターム(参考) 4C081 AC10 BB05 BB07 BB08 CA021 CA131 CB052 CC01 CC04 DA03 DC04 DC05 EA03 EA04 EA06 4C167 AA06 AA07 AA55 AA56 BB02 BB06 BB11 BB12 BB13 BB26 BB28 CC08 CC09 CC29 DD01 GG04 GG06 GG37 HH01 HH17─────────────────────────────────────────────────── ─── Continued front page (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), OA (BF , BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, G M, KE, LS, MW, MZ, SD, SL, SZ, TZ , UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, B Z, CA, CH, CN, CR, CU, CZ, DE, DK , DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, J P, KE, KG, KP, KR, KZ, LC, LK, LR , LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, R O, RU, SD, SE, SG, SI, SK, SL, TJ , TM, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW F-term (reference) 4C081 AC10 BB05 BB07 BB08 CA021 CA131 CB052 CC01 CC04 DA03 DC04 DC05 EA03 EA04 EA06 4C167 AA06 AA07 AA55 AA56 BB02 BB06 BB11 BB12 BB13 BB26 BB28 CC08 CC09 CC29 DD01 GG04 GG06 GG37 HH01 HH17
Claims (32)
択された材料から形成された中間層と、 iii)第2材料から形成された外部層とを含む少なくとも3つの層を有した
部分を有する医療用バルーンにおいて、 前記中間層は、前記内部層及び外部層の間に設けられ、第1材料及び第2材料
は中間層の材料と異なる医療用バルーン。1. An inner layer formed of i) a first material, ii) an intermediate layer formed of a material selected from the group consisting of fluorinated copolymers and linear high density polyethylene, and iii) a second material. In the medical balloon having a portion having at least three layers including an outer layer formed from, the intermediate layer is provided between the inner layer and the outer layer, and the first material and the second material are intermediate. A medical balloon that is different from the material of the layers.
項1に記載の医療用バルーン。2. The medical balloon according to claim 1, wherein the fluorinated copolymer is PTFE or EPTFE.
維は曲折している請求項2に記載の医療用バルーン。3. The medical balloon according to claim 2, wherein the EPTFE has a structure of knot points and fibrils, and the fibrils are bent.
トマー材料及び熱可塑性エラストマー材料から成るグループから選択された材料
から形成されている請求項1に記載の医療用バルーン。4. The medical balloon of claim 1, wherein the inner layer and the plurality of layers are each formed of a material selected from the group consisting of thermoplastic materials, elastomeric materials and thermoplastic elastomeric materials.
ている請求項1に記載の医療用バルーン。5. The medical balloon according to claim 1, wherein the intermediate layer extends over substantially the entire length of the medical balloon.
の医療用バルーン。6. The medical balloon includes a proximal body portion, a proximal cone portion, a body portion, a distal cone portion, and a distal body portion, and the intermediate layer is The medical balloon of claim 1, wherein the balloon extends over at least a portion of the body portion.
の医療用バルーン。7. The medical balloon of claim 6, wherein the intermediate layer extends only on the body portion.
のみに亙り延伸している請求項6に記載の医療用バルーン。8. The medical balloon according to claim 6, wherein the intermediate layer extends over at least a part of the conical portions on the proximal side and the distal side.
くとも一部のみに亙り延伸している請求項7に記載の医療用バルーン。9. The medical balloon according to claim 7, wherein the intermediate layer extends over at least a part of the proximal and distal body portions and the main body portion.
している請求項1に記載の医療用バルーン。10. The medical balloon according to claim 1, wherein the inner layer, the intermediate layer, and the outer layer extend in the same range as each other.
積層されている、積層した形態にある請求項1に記載の医療用バルーン。11. The medical balloon according to claim 1, wherein the inner layer is laminated on the intermediate layer, and the intermediate layer is laminated on the outer layer, which are in a laminated form.
求項1に記載の医療用バルーン。12. The medical balloon of claim 1, wherein the intermediate layer is surrounded by inner and outer layers.
り付けられた請求項1に記載の医療用バルーン。13. The medical balloon of claim 1 attached to a catheter having an expansion in fluid communication with the balloon.
ループから選択された材料から形成されたチューブを提供する工程と、 ii)第1材料でチューブ内部をコーティングする工程と、 iii)第2材料でチューブ外部をコーティングする工程とからなり、 前記第1材料及び第2材料は、前記チューブ材料と異なるっている請求項1に
記載の医療用バルーンを形成する方法。14. A step of: i) providing a tube formed from a material selected from the group consisting of fluorinated copolymers and high density polyethylene; ii) coating the inside of the tube with a first material; and iii) a second step. The method of forming a medical balloon according to claim 1, comprising coating the outside of the tube with two materials, wherein the first material and the second material are different from the tube material.
所定の温度でチューブを伸縮する工程を有する請求項14に記載の方法。15. By applying a predetermined tension to the balloon,
The method according to claim 14, further comprising expanding and contracting the tube at a predetermined temperature.
工程を有する請求項14に記載の方法。16. The method of claim 14 including the step of blowing the tube at a predetermined temperature and a predetermined pressure.
方法。17. The method of claim 14, wherein the first and second materials are flexible.
チレンからなるグループから選択された材料からなるチューブから形成された第
2チューブと、第3チューブとを提供する工程と、 ii)前記第1チューブを第2チューブに挿入する工程と、 iii)前記第2のチューブを第3チューブに挿入する工程と、 iv)バルーン型に前記第1、第2及び第3チューブを挿入する工程と、 v)バルーンを形成すべく好適な温度で第1、第2及び第3チューブを拡張す
る工程とからなる、請求項1に記載のバルーンを形成する方法。18. A step of: i) providing a first tube, a second tube formed of a tube made of a material selected from the group consisting of fluorinated copolymers and high density polyethylene, and a third tube; ii. ) Inserting the first tube into the second tube, iii) Inserting the second tube into the third tube, iv) Inserting the first, second and third tubes into a balloon mold The method of forming a balloon of claim 1, comprising the steps of: v) expanding the first, second and third tubes at a temperature suitable to form the balloon.
ルーン予備的形成品を形成すべく、第1材料と、PTFEの第2材料と第3材料
とを共に押出成形する工程を有する方法。19. A first material and a second and third material of PTFE are co-extruded to form a balloon preform such that PTFE forms a layer between the first and third materials. A method having a step of molding.
程を有する請求項19に記載の方法。20. The method of claim 19, comprising molding a balloon preform to form a balloon.
よって所定の温度でバルーン予備的形成品が形成される請求項20に記載の方法
。21. The method of claim 20, wherein the balloon preform is formed at a predetermined temperature by applying a predetermined tension to the balloon preform.
て、所定の温度でバルーン予備的形成品が形成される請求項20に記載の方法。22. The method of claim 20, wherein the balloon preform is formed at a predetermined temperature by blowing the balloon preform.
ューブと、第3チューブとを提供する工程と、 ii)前記第1チューブを第2チューブに挿入する工程と、 iii)前記第2チューブを第3チューブに挿入する工程と、 iv)前記第1チューブ及び第2チューブを積層する工程と、 v)少なくとも1つの3層チューブを形成すべく、前記第2チューブ及び第3
チューブを積層する工程とからなる、請求項1に記載のバルーンを形成する方法
。23. i) providing a first tube, a second tube formed from expanded PTFE, and a third tube, ii) inserting the first tube into a second tube, and iii. ) Inserting the second tube into a third tube, iv) stacking the first tube and second tube, and v) forming the second tube and the second tube to form at least one three-layer tube. Three
The method of forming a balloon of claim 1, comprising the step of stacking tubes.
する工程を有する請求項23に記載の方法。24. The method of claim 23, comprising laminating the first and third tubes at least partially together.
求項23に記載の方法。25. The method of claim 23, comprising blowing the laminate at a predetermined temperature.
と第2チューブとが、及び、前記第2チューブと第3チューブとが離層する請求
項25に記載の方法。26. The method of claim 25, wherein blowing of the balloon causes delamination of the first tube and the second tube and the second tube and the third tube.
中間層とからなる医療用バルーン。27. i) an inner layer formed of a flexible material, ii) an outer layer formed of a flexible material, and iii) an expanded PTFE provided between the inner layer and the outer layer. A medical balloon comprising a formed intermediate layer.
層及び外部層によって包囲された中間層とを少なくとも有する医療用バルーン。28. A medical balloon having at least an inner layer formed of expanded PTFE, an outer layer, and an intermediate layer surrounded by the inner layer and the outer layer.
ら形成されていることとを有する医療用バルーン。29. At least a part having at least three layers, an innermost layer, an outermost layer provided outside the innermost layer, and an intermediate layer provided between the innermost layer and the outermost layer. A medical balloon comprising a layer and the intermediate layer made of a material having a structure in which knot points are bonded by a large number of fibers.
に記載の医療用バルーン。30. The intermediate layer is formed of expanded PTFE.
The medical balloon described in.
項29に記載の医療用バルーン。31. The medical balloon of claim 29, wherein the knot points are joined by bent fibrils.
項29に記載の医療用バルーン。32. The medical balloon of claim 29, wherein the intermediate layer is formed of high density polyethylene.
Applications Claiming Priority (3)
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US09/514,929 US6756094B1 (en) | 2000-02-28 | 2000-02-28 | Balloon structure with PTFE component |
US09/514,929 | 2000-02-28 | ||
PCT/US2001/005506 WO2001064278A1 (en) | 2000-02-28 | 2001-02-22 | Balloon structure with ptfe component |
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JP2008301425A Division JP5020218B2 (en) | 2000-02-28 | 2008-11-26 | Balloon structure with PTFE parts |
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JP2003525092A true JP2003525092A (en) | 2003-08-26 |
JP4898053B2 JP4898053B2 (en) | 2012-03-14 |
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JP2001563173A Expired - Fee Related JP4898053B2 (en) | 2000-02-28 | 2001-02-22 | Balloon structure with PTFE parts |
JP2008301425A Expired - Lifetime JP5020218B2 (en) | 2000-02-28 | 2008-11-26 | Balloon structure with PTFE parts |
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Application Number | Title | Priority Date | Filing Date |
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JP2008301425A Expired - Lifetime JP5020218B2 (en) | 2000-02-28 | 2008-11-26 | Balloon structure with PTFE parts |
Country Status (8)
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US (2) | US6756094B1 (en) |
EP (1) | EP1263492B1 (en) |
JP (2) | JP4898053B2 (en) |
AT (1) | ATE294007T1 (en) |
AU (1) | AU2001243201A1 (en) |
CA (1) | CA2401400C (en) |
DE (1) | DE60110394T2 (en) |
WO (1) | WO2001064278A1 (en) |
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JP2010512978A (en) * | 2006-12-18 | 2010-04-30 | シー・アール・バード・インコーポレーテッド | Balloon with segmented fabric layers and method for braiding on a three-dimensional mold |
JP2017205555A (en) * | 2011-07-14 | 2017-11-24 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティドW.L. Gore & Associates, Incorporated | Expandable medical devices |
JP2014520632A (en) * | 2011-07-14 | 2014-08-25 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド | Expandable medical device |
JP2018075446A (en) * | 2012-03-09 | 2018-05-17 | クリアストリーム・テクノロジーズ・リミテッド | Parison for forming blow molded medical balloon with modified portion, medical balloon, and related methods |
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JP2016506271A (en) * | 2012-12-19 | 2016-03-03 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティドW.L. Gore & Associates, Incorporated | Medical balloon device and method |
JP2019055259A (en) * | 2013-08-28 | 2019-04-11 | クリアストリーム・テクノロジーズ・リミテッド | Methods for providing radiopaque medical balloons |
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Also Published As
Publication number | Publication date |
---|---|
US7682553B2 (en) | 2010-03-23 |
EP1263492B1 (en) | 2005-04-27 |
DE60110394T2 (en) | 2006-02-09 |
JP5020218B2 (en) | 2012-09-05 |
US6756094B1 (en) | 2004-06-29 |
US20040170782A1 (en) | 2004-09-02 |
DE60110394D1 (en) | 2005-06-02 |
AU2001243201A1 (en) | 2001-09-12 |
WO2001064278A1 (en) | 2001-09-07 |
JP4898053B2 (en) | 2012-03-14 |
CA2401400C (en) | 2008-07-08 |
JP2009101170A (en) | 2009-05-14 |
ATE294007T1 (en) | 2005-05-15 |
EP1263492A1 (en) | 2002-12-11 |
CA2401400A1 (en) | 2001-09-07 |
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